Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

Phase 3

Completed

Conditions: Irritable Bowel Syndrome With Constipation

Interventions: Drug: Placebo
Drug: Lubiprostone

Registration Number: NCT00380250

Lead Sponsor: Sucampo Pharma Americas, LLC

Brief Summary: The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 590

Inclusion Criteria

18 years of age and older
Stable fiber therapy
Normal colonoscopy/sigmoidoscopy
Able to refrain from use of medications known to treat or associated with constipation symptoms
Experiences abdominal discomfort/pain associated with bowel movements
Reports decreased bowel movement frequency and/or other symptoms associated with constipation

Exclusion Criteria

Diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable bowel syndrome (IBS), or constipation other than that associated with IBS
Open gastrointestinal or abdominal surgery prior to IBS onset
Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo capsule twice daily (BID)
Lubiprostone	Lubiprostone	8 mcg capsule twice daily (BID)

Primary Outcome Measures

Name	Time	Method
Overall Responder Rate	12 weeks	Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. Overall responder: responder for at least 2/3 months

Secondary Outcome Measures

Name	Time	Method
Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline	Change from baseline for month 1	SBMs are any bowel movement not associated with rescue medication use.
Quality of Life Change From Baseline	Change from baseline at 12 weeks	Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase
Month 3 Bowel Straining Change From Baseline	Change from baseline for month 3	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 1 Constipation Severity Change From Baseline	Change from baseline at 28 days	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 1 Symptom Relief	Change from baseline for month 1	Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3
Month 2 Stool Consistency Change From Baseline	Change from baseline for month 2	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Month 3 Responder Rate	month 3 (28 days)	Symptoms \>= Moderately relieved for 4 weeks/month or Significantly relieved for \>=2 weeks/month AND: 1. Rescue medication use does not increase during the month as compared to baseline; 2. No discontinuation during the month due to lack of efficacy;AND 3. No ratings during the month of Moderately worse or Significantly worse.
Month 3 Abdominal Bloating Change From Baseline	Change from baseline for month 3	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline	Change from baseline for month 2	Any bowel movement not associated with rescue medication use
Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline	Change from baseline for month 3	Any bowel movement not associated with rescue medication use
Month 1 Bowel Straining Change From Baseline	Change from baseline for month 1	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 2 Responder Rate	month 2 (28 days)	Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Month 2 Abdominal Bloating Change From Baseline	Change from baseline for month 2	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 3 Constipation Severity Change From Baseline	Change from baseline for month 3	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 1 Stool Consistency Change From Baseline	Change from baseline for month 1	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Month 1 Responder Rate	month 1 (28 days)	Symptoms \>= Moderately relieved for 4 weeks/month or Significantly relieved for \>=2 weeks/month AND: 1. Rescue medication use does not increase during the month as compared to baseline; 2. No discontinuation during the month due to lack of efficacy;AND 3. No ratings during the month of Moderately worse or Significantly worse.
Month 3 Stool Consistency Change From Baseline	Change from baseline for month 3	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Month 2 Bowel Straining Change From Baseline	Change from baseline for month 2	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 3 Symptom Relief	Change from baseline for month 3	Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3
Month 1 Bowel Movement Frequency Rates Change From Baseline	Change from baseline for month 1
Month 1 Abdominal Pain Change From Baseline	Change from baseline for month 1	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 2 Abdominal Pain Change From Baseline	Change from baseline for month 2	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 2 Constipation Severity Change From Baseline	Change from baseline for month 2	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 2 Symptom Relief	Change from baseline for month 2	Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3
Month 1 Abdominal Bloating Change From Baseline	Change from baseline for month 1	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 2 Bowel Movement Frequency Rates Change From Baseline	Change from baseline for month 2
Month 3 Bowel Movement Frequency Rates Change From Baseline	Change from baseline for month 3
Month 3 Abdominal Pain Change From Baseline	Change from baseline for month 3	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe